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Completed

NCT Number: NCT04859023

Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection (COVID-19).

The virological diagnosis of SARS-CoV-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. Despite nasopharyngeal swabbing tested by RT-PCR is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. The aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. The comparison will be performed during a mass screening of the population of the city of Saint-Etienne (170000 inhabitants), France. The sensitivity of the rapid antigenic test will be evaluated in comparison to that of RT-PCR considered as gold standard.

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Key information

Conditions

SARS-CoV Infection Adherence Interventions Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Disease Health Behavior Health Education Infections Lung Diseases Medication Adherence Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Treatment Adherence and Compliance Virus Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

The main objective is to evaluate the performance of a strategy for screening for CoV-2-SARS infection that would combine 1) a salivary self-sample with an anterior nasal swab and 2) a diagnostic antigenic test, in comparison with the reference salivary RT-PCR technique recently validated by National Authority for Health (HAS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing
  • Subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research

Exclusion criteria

  • Inability to understand the protocol (language barrier notably)
  • Deny to participate to the proposed research
  • Patients under tutorship

Treatment and study plan

saliva sample combined to an anterior nare self-swabbing (Self-samples)

Diagnostic Test

Tested by antigenic test.

saliva sample (Self-sample)

Diagnostic Test

Tested by RT-PCR.

Survey of SARS-COV-19 knowledge

Other

collection of : socio-professional characteristics, questions on health literacy on the transmission of the virus and barrier gestures, adherence to barrier gestures, isolation modalities in case of positivity, motivations for participating in this screening campaign.

Survey of acceptability of the different self-samples.

Other

collection of : assessment and acceptability of the tolerance of self-samples.

Primary outcomes

  1. Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard).

    Time frame: Day: 7

    Measured by antigenic test results and RT-PCR results.

Secondary outcomes

  1. Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva

    Time frame: Day: 7

    Measured by RT-PCR results.

  2. Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population

    Time frame: Day: 7

    Measured by RT-PCR results.

  3. Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories

    Time frame: Day: 7

    Measured by survey of acceptability of the different self-samples results.

  4. Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)

    Time frame: Day: 7

    Measured by number of test performed and performances of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR.

  5. Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign

    Time frame: Day: 7

    Measured the screening day.

  6. Number of persons cared for by the territorial isolation support cell (CTAI)

    Time frame: Day: 7

    Measured the screening day.

  7. Health literacy questionnaire

    Time frame: Day: 7

    It is a questionnaire with items on the transmission of the virus and barrier gestures, adherence to barrier gestures, modalities of isolation in case of positivity and motivations for participating in this screening campaign.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection in General Population Using Self-samples (COVID-19).

Acronym: AutoCoV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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